Spinal Cord Injury-Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD (SATURN Study): Protocol of An Exploratory Study In Assessing the Safety and Efficacy of NeuroAiD Amongst People Who Sustain Severe Spinal Cord Injury

Ramesh Kumar, Ohnmar Htwe, Azmi Baharudin, Mohammad Hisam Ariffin, Shaharuddin Abdul Rhani, Kamalnizat Ibrahim, Aishah Rustam, Robert Gan, Ramesh Kumar, Ohnmar Htwe, Azmi Baharudin, Mohammad Hisam Ariffin, Shaharuddin Abdul Rhani, Kamalnizat Ibrahim, Aishah Rustam, Robert Gan

Abstract

Background: Spinal cord injury (SCI) is a devastating condition with limited therapeutic options despite decades of research. Current treatment options include use of steroids, surgery, and rehabilitation. Nevertheless, many patients with SCI remain disabled. MLC601 (NeuroAiD), a combination of natural products, has been shown to be safe and to aid neurological recovery after brain injuries and may have a potential role in improving recovery after SCI.

Objective: The aim of this study is to evaluate the safety and efficacy of NeuroAiD amongst people who sustain SCI in the study setting.

Methods: Spinal Cord Injury-Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD (SATURN) is a prospective cohort study of patients with moderately severe to severe SCI, defined as American Spinal Injury Association (ASIA) Impairment Scale (AIS) A and B. These patients will be treated with open-label NeuroAiD for 6 months in addition to standard care and followed for 24 months. Anonymized data will be prospectively collected at baseline and months 1, 3, 6, 12, 18, and 24 and will include information on demographics; main diagnostics; and neurological and functional state assessed by the Spinal Cord Independence Measure, ASIA-International Standard for Neurological Classification Spinal Cord Injury, and Short Form (SF-8) Health Survey. In addition, NeuroAiD treatment, compliance, concomitant therapies, and side effects, if any, will be collected. Investigators will use a secured online system for data entry. The study is approved by the ethics committee of Hospital University Kebangsaan Malaysia.

Results: The coprimary endpoints are safety, AIS grade, and improvement in ASIA motor score at 6 months. Secondary endpoints are AIS grade, ASIA motor scores and sensory scores, Spinal Cord Independence Measure (SCIM), SF-8 Health Survey, and compliance at other time points.

Conclusions: SATURN investigates the promising role of NeuroAiD in SCI especially given its excellent safety profile. We described here the protocol and online data collection tool we will use for this prospective cohort study. The selection of moderately severe to severe SCI provides an opportunity to investigate the role of NeuroAiD in addition to standard rehabilitation in patients with poor prognosis. The results will provide important information on the feasibility of conducting larger controlled trials to improve long-term outcome of patients with SCI.

Trial registration: Clinicaltrials.gov NCT02537899; https://ichgcp.net/clinical-trials-registry/NCT02537899 (Archived by WebCite at http://www.webcitation.org/6m2pncVTG).

Keywords: MLC601; MLC901; NeuroAiD; efficacy; recovery; safety; spinal cord injury.

Conflict of interest statement

This study is supported in part by Moleac Singapore Pte Ltd, 11 Biopolis Way #09-08 Helios, Singapore 138667. RK has received support for clinical trials and presentations at scientific meetings from Moleac Singapore. AR and RG are employees of Moleac Singapore. Other than support for this study, the other authors have no other competing interests to declare.

©Ramesh Kumar, Ohnmar Htwe, Azmi Baharudin, Mohammad Hisam Ariffin, Shaharuddin Abdul Rhani, Kamalnizat Ibrahim, Aishah Rustam, Robert Gan. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 05.12.2016.

Figures

Figure 1
Figure 1
Spinal Cord Injury—Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD (SATURN) study flowchart.

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